MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-011-000
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer the device was bent after validation which can lead to inaccuracies.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d3, d5, g1, h3 and h4.H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
Per the customer the device was bent after validation which can lead to inaccuracies.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: LARGE POINTER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg MI D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18409037
• Report Number: 3015967359-2023-02663
• Device Sequence Number: 2690656
• Product Code: HAW
• UDI-Device Identifier: 04546540245106
• UDI-Public: 04546540245106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6000-011-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown